Clinical Trials for Head And Neck Cancer

A Phase 1/2 Immunotherapy Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab in Patients with Advanced Solid Malignancies

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with metastatic CRPC, pancreatic cancer, or HPV-negative SCCHN lacking effective options receive triplet therapy with evofosfamide (hypoxia-activated DNA crosslinking prodrug) plus zalifrelimab (anti–CTLA-4) and balstilimab (anti–PD-1). Open-label dose-escalation followed by disease-specific expansions; key exclusions include significant prior immune toxicity, active autoimmune disease, QTc ≥470 msec/TdP risk, uncontrolled CNS disease/infections, and use of strong/moderate CYP3A4 modulators or QT-prolonging drugs.

ClinicalTrials.gov ID: NCT06782555

A Phase 1/2 Open-Label, Umbrella Platform Design Study of MK-2870 With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: First-line study in adults with HER2-negative (or not known positive) unresectable/metastatic gastric/GEJ/esophageal adenocarcinoma (ECOG 0–1) comparing pembrolizumab plus fluoropyrimidine/oxaliplatin chemotherapy versus the same backbone combined with sacituzumab tirumotecan (MK-2870), a TROP2-directed antibody–drug conjugate delivering a belotecan-derived topoisomerase I inhibitor. Safety lead-in determines RP2D, then randomized assessment of response, PFS, and OS.

ClinicalTrials.gov ID: NCT06469944

A Phase 1/2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of MK-2870 Plus Paclitaxel as the Second-Line Treatment of Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma: Substudy 06D

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic gastric/GEJ/esophageal adenocarcinoma after exactly one prior platinum/fluoropyrimidine regimen (HER2-negative or unknown) are randomized to sacituzumab tirumotecan (TROP2-directed ADC with a topoisomerase I payload) plus paclitaxel versus standard ramucirumab plus paclitaxel. Excludes squamous histology and patients with significant comorbidities (e.g., grade ≥2 neuropathy, ocular surface disease, active CNS mets, recent arterial events, prior VEGF/VEGFR therapy, or prior TROP2/topo I ADCs).

ClinicalTrials.gov ID: NCT06445972

A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with unresectable, advanced/metastatic gastric/GEJ/esophageal adenocarcinoma (HER2‑negative, MSS/pMMR) in the 2L setting and ESCC in 1L or 2L receive the anti‑CCR8 monoclonal antibody CHS‑114 (depletes intratumoral CCR8+ Tregs via enhanced ADCC/ADCP) plus the PD‑1 inhibitor toripalimab, with cisplatin/5‑FU added in 1L ESCC. Requires measurable disease and tissue; excludes active CNS metastases and prior anti‑CCR8.

ClinicalTrials.gov ID: NCT06657144

Decentralized Pilot Study of Triple Oral Metronomic Chemotherapy for Patients With Recurrent/Metastatic Oral Cavity Cancer in a Rural Midwest United States Population

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: Adults with recurrent/metastatic oral cavity cancer after or ineligible for standard first-line immunotherapy/chemo-immunotherapy (ECOG 0–2) receive a fully oral metronomic regimen of methotrexate (antifolate), erlotinib (EGFR TKI), and celecoxib (COX‑2 inhibitor) in 28‑day cycles, delivered with decentralized/virtual components. Excludes significant cardiac risk, active serious infection/bleeding, uncontrolled viral hepatitis/HIV, pregnancy, and concurrent investigational therapy.

ClinicalTrials.gov ID: NCT06997068

A Phase 2 Trial of Intraoperative Fluorescent Angiography to Decrease Pharyngocutaneous Fistula Rates in Patients Undergoing Hypopharyngeal Reconstruction

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: Adults with previously irradiated stage II–IV laryngeal or hypopharyngeal squamous cell carcinoma undergoing salvage total laryngectomy receive intraoperative indocyanine green (ICG) fluorescence angiography with the SPY system to assess mucosal perfusion, with resection of hypoperfused tissue prior to reconstruction. ICG is a near-infrared fluorescent dye used for real-time perfusion imaging, aiming to reduce postoperative pharyngocutaneous fistula, particularly in intraoperatively defined high-risk cases.

ClinicalTrials.gov ID: NCT06831149

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Enrolling adults with previously untreated locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ECOG 0–1) and measurable disease. Patients receive pembrolizumab plus mFOLFOX6 (control) or pembrolizumab combined with an antibody–drug conjugate: ifinatamab deruxtecan (B7-H3/CD276–targeted ADC delivering a cleavable topoisomerase I inhibitor payload [DXd]) with or without fluoropyrimidine/leucovorin ± oxaliplatin, or sacituzumab tirumotecan (TROP2-directed ADC with a topoisomerase I inhibitor payload) plus fluoropyrimidine/leucovorin.

ClinicalTrials.gov ID: NCT06780111

A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination With Budigalimab (ABBV-181) in Adult Subjects With Advanced Squamous Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Enrolling adults with advanced/metastatic squamous malignancies (including squamous NSCLC and head and neck SCC) that have progressed after or are not candidates for standard therapies, with measurable disease; prior PD-1/PD-L1 therapy is allowed and tumor tissue/biopsies are required for biomarker analyses in some cohorts. Patients receive oral ABBV-711 (mechanism/target not publicly disclosed) as monotherapy or in combination with budigalimab (ABBV-181), an engineered anti–PD-1 IgG1 monoclonal antibody.

ClinicalTrials.gov ID: NCT07241039

A Phase I Study of Zanzalintinib With Pembrolizumab and Cetuximab in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Enrolling adults with incurable recurrent/metastatic head and neck squamous cell carcinoma (ECOG 0–1, measurable disease), including previously untreated R/M disease only if PD-L1 CPS ≥1 or patients previously treated with anti–PD-(L)1 therapy (no PD-L1 restriction), excluding prior EGFR inhibitors/cetuximab or VEGFR-targeted therapy and >2 prior systemic lines in the R/M setting. Patients receive oral zanzalintinib (investigational multi-kinase TKI targeting VEGFR2, MET, and TAM kinases) daily plus pembrolizumab (anti–PD-1) and cetuximab (anti-EGFR) IV in 42-day cycles with dose escalation/expansion to define the RP2D.

ClinicalTrials.gov ID: NCT06912087

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with centrally confirmed MTAP homozygous loss/deletion and advanced solid tumors (ECOG 0–1) who have progressed after standard therapy are enrolled in dose escalation (mesothelioma, gastroesophageal, NSCLC, urothelial), with dose-expansion limited to MTAP-deleted NSCLC after platinum chemotherapy and PD-1/PD-L1 therapy (≤3 prior lines, prior appropriate targeted therapy if actionable). Participants receive IDE892, an MTA-cooperative PRMT5 inhibitor, as monotherapy or combined with IDE397, an oral MAT2A inhibitor, in 21-day cycles.

ClinicalTrials.gov ID: NCT07277413